Phase 2 Osprey, Apteryx studies of QLS-111 meet all endpoints
Key takeaways:
- Patients with primary open-angle glaucoma or ocular hypertension achieved lower IOP.
- All concentrations of QLS-111 were safe and well tolerated.
Patients with primary open-angle glaucoma or ocular hypertension who received QLS-111 experienced lower IOP in two phase 2 trials, according to a press release from Qlaris Bio.
The Osprey and Apteryx studies of QLS-111, a topical formulation using the company’s ATP-sensitive potassium channel modulator platform that targets episcleral venous pressure, met all primary and secondary endpoints.
The masked, randomized Osprey study was designed to assess the safety, tolerability and IOP-lowering activity of QLS-111 in a range of doses compared with vehicle in 62 adult patients. The 0.015% concentration helped patients achieve the greatest decrease in IOP, with a mean reduction of 3.7 mm Hg from a baseline IOP of 23 mm Hg, according to the release.
The masked, randomized Apteryx study assessed the safety, tolerability and additive IOP-lowering efficacy of QLS-111 with latanoprost compared with latanoprost alone in 32 patients aged 12 years or older who were stable on latanoprost alone. In the patients who received QLS-111 0.015% and latanoprost, the mean IOP reduction was 3.2 mm Hg greater for once-daily dosing and 3.6 mm Hg greater for twice-daily dosing compared with latanoprost alone, according to the release.
All concentrations and dose regimens of QLS-111 were well tolerated and had good safety profiles in both studies. There were no serious adverse events.
“The data show QLS-111’s synergistic ability to provide significant IOP lowering in patients already on latanoprost,” Barbara Wirostko, MD, FARVO, chief medical officer of Qlaris Bio, said in the release. “This substantial additive effect demonstrates the potential to significantly benefit patients who do not achieve IOP-lowering goals with current therapies. Additionally, we believe the promising tolerability profile of QLS-111 will further enhance the value to our patients by driving improved treatment compliance and adherence. This is supported by the absence of clinically relevant hyperemia, with no corneal changes and no clinically relevant ocular or systemic findings thus far in our studies.”
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